Intra-uterine contraceptive devices

ABSTRACT

An intra-uterine contraceptive device comprising a longitudinally rigid, transversely resiliently compressible body having each of its longitudinal ends expansible upon compression of the other; means limiting the expansion of one of its ends formed of a resiliently pliable material molded on said body at said end and along its side edges; the resiliently pliable material projecting beyond said body at said end to provide a compressible, longitudinally deformable extension of said body. The limiting means and the extension include a diaphragm across the width of the body; the diaphragm defined by thickened ribs along its free edge portions.

United States Patent [151 3,683,905 Cha t [45.] Aug. 15, 1972 [54] INTRA-UTERINE CONTRACEPTIVE 3,516,403 6/1970 Coumut ..l28/ 130 DEVICES 3,563,235 2/1971 Zipper ..128/130 [72] Inventor: 22:2 fig g g Tnpplet Primary Examiner-Lawrence Charles AttorneyVictorM.1- 1e1fand [22] Filed: March 16, 1970 21 Appl. No.: 19,963 [57] ABSTRACT An intra-uterine contraceptive device comprising a longitudinally rigid, transversely resiliently compressi- (g1 ble body having each of its longitudinal ends expansi 58] Fie'ld l28/130 ble upon compression of the other; means limiting the expansion of one of its ends formed of a resiliently pliable material molded on said body at said end and [56] References Cited along its side edges; the resiliently pliable material UN T STATES A E projectingbgieypnd saig bgiiy gtfsaid (and to provide 1;

compressi e, ongitu in y e orma e extension 0 3,256,878 6/1966 Schwartz et a1. ..l28/13 said body. The limiting means and the extension in- 3,397,691 8/1968 Majlllrl ..128/130 elude a diaphragm across the width f the body; the 3,405,711 10/1968 Bakunm ..128/130 diaphragm defined by thickened ribs along its free 3,467,089 9/1969 Hasson ..128/130 edge portions 3,490,446 1/1970 Slonek et a]. 128/130 3,507,274 4/ 1970 Soichet 128/ 130 14 Claims, 9 Drawing Figures PATENTEDAUE 15 I912 3.683; 905

SHEEI 1 OF 2 FIG.I FIG.2 H63 MARC E. CHAFT INVENTOR.

PATENTEDAUB 15 I972 SHEEI 2 OF 2 MARC ECHAFT IVVENTOR BY I Ai "TORNEY lNTRA-UTERINE CONTRACEPTIVE DEVICES The present invention relates to intra-uterine' contraceptive devices and presents improvements over the devices described and claimed in my Pat. No. 3,410,265, dated Nov. 12, 1968, and in my co-pending application Ser. No. 742,984, filed July 5, 1968.

In my said patent and application, I have described and claimed intra-uterine contraceptive devices formed of elements connected to one another, by arcuate, resilient joints, at an angle to one another, in extended arrangement, and compressible tobring the elements into substantial contact with one another, to reduce the cross-section of the device for insertion into a uterine cavity. The devices are described as being formed of leaf spring material arranged in a single plane or of wire arranged in two parallel planes; in M- shape or in spiral shape. Such devices are disposed in the uterus with theconnected ends facing the fundus and the end of the device having the end elements with the free ends facing the uterine entrance.

Intra-uterine contraceptive devices (for brevity, hereinafter referred to as IUCDs) of the type referred to above, have been found, in many instances, to produce discomfort and bleeding and other damage to the walls of the uterus. Such bleeding may be due to the sharpness of the edges of the device, or to the free ends of its end elements that may, as a result of the muscular activity of the uterine walls, impinge against the walls and dig into or abrade their surfaces. The present invention, therefore, is directed to the provision of IUCDs which will greatly reduce, if not eliminate, damage from said causes to the uterine walls.

Bleeding that may be caused by the action'of the ends of the elements of an M -shaped device may be due to the compression of the inner end of the device, at the fundus, by muscular activity of the uterine muscles at that end. Such compression may result in the spreading apart of the free ends of its end elements to cause such ends to press forcefully against the side walls of the uterus, to abrade or even cut them. The present invention is, therefore, directed to the provision of IUCDs in which the spreading apart of the end elements of the device is limited, regardless of the compression of the inner, connected ends of such elements; and is further directed to such device in which the spread-limiting means does not affect the compressibility of such ends of the end elements of the device towards one another.

Bleeding caused by the action of the ends of the end elements of the IUCDs may also be occasioned by the shape or size of the uterus in individual persons. While the uterus is generally pictured as lying with its wide sides in substantially flat, horizontal plane, approxi mately normal to the spine, the actual shape of the uterus varies in individual women, particularly after childbirth. Thus, a uterus may be disposed within the body in a curved plane. Since IUCDs of the general type to which the presentinvention relates have been substantially rigid in a longitudinal direction, and formed to lie in a flat plane, the chance of damage to the uterine walls by the ends of such devices which are not longitudinally flexible to a longitudinally-curved uterus, is enhanced. The present invention, therefore, is. also directed to the provision of IUCDs, the character described, which are at least partly flexible longitudinally and, therefore, longitudinally more conformable to the uterus which is longitudinally curved.

A uterus may vary in length and width in different women and even in the same woman ,at different periods of her life, as before and after pregnancy. The present invention, therefore, is further directed to the provision of lUCDs that are readily conformable to variations in uterine length and width, without exerting any undue pressure against the walls of a uterus of shorter or narrower shape.

Further, mechanical IUCDs of the category to which the types of the devices of the present invention belong are believed to attain their contraceptive effect by spacing the wider, upper and lower walls of the uterus, thus inhibiting the implantation of a fertilized ovum in said walls. However, such mechanical devices fail in a percentage of their use to prevent conception; it is be lieved, because they fail, for various reasons, to separate the uterine walls and to prevent the passage of fluid between them, to completely prevent implantation of a fertilized ovum between the uterine walls. The present invention, therefore, is also directed to the provision of mechanical IUCDs which will produce a greatly reduced incidence of contraceptive failures, if not substantially eliminate such failures, by inhibiting contact between at least a substantial area of the facing walls of the uterus, at the same time dividing the space between them and preventing the: interchange of fluids between them over the area. I

In many instances, the walls of the uterus tend to encompass and enclose between them the elements of an IUCD of the type described, by growing around such elements. The withdrawal of the IUCD under such circumstances becomes painful and dangerous. The present invention, therefore, also contemplates the provision of IUCDs which will inhibit the enclosure of the elements of the device by the walls of the uterus, leaving the device relatively loose within the uterus for easy and non-harming removal. 7

Still further, individual women using the IUCDs may desire to retain such IUCD for different lengths of time. Thus, a woman who has given birth to her full, desired component of children, may desire to have the IUCD remain in situ for as long as possible. On the other hand, a woman who has not yet given birth, or who plans'for additional children, may desire to have the IUCD readily removable, without pain and without damage to the uterus. The present invention, therefore, is further directed to the provision of IUCDs which may be shaped to either remain in the uterus with a minimum chance of being inadvertently discharged therefrom; or so shaped that it may be readily withdrawn from the uterus when conception is desired, even when the outer end of the uterus is of relatively substantial width and forms shoulders at the sides of the uterine outlet.

The foregoing and other objects and advantages of the intra-uterine contraceptive devices of the. present invention will become more readily apparent to those skilled in the art from the embodiments thereof shown in the accompanying drawings and from the description following. vIt is to be understood, however, that such embodiments are shown by way of illustration only, to make the principles and practice of the invention more readily comprehensible, and without any intent of limiting the invention to the specific details therein shown.

In the drawings:

FIG. 1 is a plan view of one embodiment of an intrauterine contraceptive device of the present invention;

FIG. 2 is a side edge view of the same;

FIG. 3 is a plan view of a device of FIG. 1, shown as compressibly distorted to shorten it and narrow its outer end in response to muscular contraction of the outer end of the uterus and for conforming to the shape thereof;

FIG. 4 is a more or less diagrammatic depiction of a device of FIG. 1, shown as longitudinally distorted within a curved uterus;

FIG. 5 is a modified embodiment of a device of the type shown in FIG. 1;

FIG. 6 is a further modified embodiment of a device of the type of FIG. 1;

FIG. 7 is a plan view of'a spiral type of a device embodying the principles of the invention;

FIG. 8 is an edge view taken of the device of FIG. 7; and

FIG. 9 is a section taken on line 9-9 of FIG. 7.

Generally stated, the invention resides in the enclosing of at least the outer elements of a transversely compressible IUCD in a sheath or coating formed of relatively soft, pliable material, inert to body fluids, such as natural or synthetic latex, as the synthetic plastic material known under the trade name of Silastic", and providing a continuous film between the sheath portions on the outer elements of the device to thereby limit the degree of separation between them, and in providing rib extensions of the plastic material on the outer elements projecting beyond the outer elements of the device, with the film continuing between such extensions, to thereby render that portion of the device yieldably conformable to the shape and length of the uterus and to the pressure of its muscular contractions at its outer end.

Referring more specifically to the accompanying drawings, and with particular reference to the embodiment of FIGS. 1, 2 and 3 thereof, the same illustrate an IUCD of the M-shape type, generally designated as 20, formed, preferably, of leaf spring material and consisting of end elements, 22, each connected at a corresponding end to an intermediate element 24, by an enlarged, arcuate bight or joint, 26, for easy flexing; the elements 24 normally being disposed at an angle to the elements 22, which may preferably be substantially parallel to one another, and are connected to one another at their other ends by a similar bight, 28. Elements 22 may preferably have their free ends slightly curved in the direction of one another and may be of such length that when in extended position they are in a line with one another and with the bottom of bight 28.

- A coating or sheath, 30, of an inert material, such as the plastic material known under the trade name Silastic is molded around elements 22 and 24, and their connecting bights 26 and 28, and an integral, thin diaphragm, 32, of the same material is formed across the space between the elements. The sheath 30 encompassing elements 22 and 24 is substantially thicker than the elements encompassed by it, and comprise rib-like formations. The thickened sheath portions 30 over elements 22 are extended as relatively thickened, flexible rib portions, 34, beyond the free ends of elements 22, to lengthen the device, and the end portions of ribs 34 are inwardly offset in the direction of one another to merge into a string-like extension, 36; the diaphragm 32 continuing between the rib extensions 34 to form an apron, 38, as an extension of diaphragm 32.

In the device of FIGS. 1, 2 and 3, the ends of rib extensions 34 are offset towards one another on a substantially straight line, to thereby substantially square the outer end of the device 20, for more permanent retention within a uterus.

In the device of FIG. 5, the end portions of ribs 34a converge outwardly at an angle to one another, to form a substantially triangular apron, 38a, and is suitable for use within a uterus of a woman who may desire to have the same withdrawn at more or less frequent intervals or whose outer uterus end is squared off to form shoulders to each side of the uterus outlet; the converging portions of ribs 34a making possible the avoiding of such shoulders during the withdrawal from the uterus.

It will be apparent that, while the diaphragm portion 32 will inhibit and limit the spread of the free ends of elements 22, to thereby avoid their disposal at an increased angle to the side walls of the uterus when their other ends near the fundus are compressed toward one another, the portion of the device defined by ribs 34 or 34a and aprons 38 or 38a are both longitudinally and laterally conformable to fit within a uterus having a curved outer end, as illustrated in FIG. 4, or to be narrowed and shortened to fit within a uterus of shorter length.

It will also be apparent that in devices such as of FIGS. 1 to 5, sharp edges as well as sharp element ends are eliminated, to greatly reduce the possibility of causing damage to or bleeding from the uterine walls, and that the film diaphragms 32 and 38 prevent the walls of the uterus from growing around and deeply encompassing the device, and also divide the vertical uterine space and interfere with the interchange of fluid between the uterine walls, to greatly reduce the percentage of contraceptive failures, such as occurred with the use of IUCDs of the prior art, of the general type to which the devices of the present invention relates.

In FIG. 6 there is illustrated an M-shaped IUCD 20b, in which there is secured to the portions of the sheath 30b encompassing end elements 22b, on their exterior, a relatively soft, easily compressible pad, 40, between the outer or end portion of which and the sheath 30b, adjacent the free ends of elements 22b, there is disposed an intermediate pad, 42, of resilient material of lesser compressibility. Pads 40 and 42 tend to cushion the transverse pressure of the muscular contraction of the uterus against the device and make it more gradual, and thereby further reduce the likelihood of damage to the end walls of the uterus.

FIGS. 7, 8 and 9 of the drawings illustrate the adaptation of the principles of the present invention to a spiral type IUCD, of the same general type described and claimed in my said co-pending application. The device, generally designated as 50, comprises a plurality of elements including intermediate elements, 52, connected at each of their ends by an arcuate, resilient bight, 54, to an adjacent element 52, at an angle to one another; alternate of said elements lying in a plane parallel to the other elements. Device 50 also includes end elements connected by one end by a resilient bight 54 to an adjacent element 52, and having their free ends extending in the same direction. Each end element, 56, is pressed inwardly to have its free end disposed in close proximity to the end of the adjacent element 52, to thereby impart to the device 50 a tapered shape, with the narrower end thereof forming the outer end of the device which is to face the uterine inlet.

In the embodiment of FIGS. 7, 8 and 9, each outer element 56 is held in the above-described position by a sheath or strip, 58, formed of inert material, such as natural or synthetic rubber latex, as Silastic, and which encompasses and connects each element 56 and its adjacent element 52 and forms a relatively thickened riblike formation, 60, along each side edge of the spiral device 50. The lower or outer ends of rib 60 may be connected to one another by a preferably relatively thinner transverse molded rib, 62, that encompasses the lower bights 54 connecting the lower ends of elements 52. Each rib 60 may be formed with an alined extension, 64, at its outer end, the end portions of which extensions are offset towards one another, either laterally, as illustrated, or convergently, as in FIG. 5, and joined to form a string extension, 66. Ribs 62 and rib extensions 60 are connected by a diaphragm forming an apron, 68.

It may here be stated that the relatively stiffly compressible metal portion in the IUCDs of the present invention, whether in the M shape or in the spiral shape, may be relatively short, but sufficient to maintain the device, when within the uterus, in normally extended position, in the wider area of the uterus adjacent the fundus; the other part of the length of the device being composed of the resilient pliable rib extensions and the diaphragm between them, that are more readily compressible and conformable to the length of the uterus and to its longitudinal and horizontal shape.

This completes the description of the several forms of the lUCDs of the present invention. It will be readily apparent that such devices, because of their sheathed end elements and because of the resilient pliability of the rib extensions of such sheaths that renders the devices more readily conformable to variations in uterine size and shape, will make the devices safer to use and less likely to cause bleeding from or damage to uterine walls. It will also be apparent that the presence of the diaphragm in such devices, which form positive separations between at least parts of the uterine walls and interfere with the flow of body fluids between the uterine walls, the efficacy of the devices as contraceptives will be enhanced. It will likewise be apparent that the devices of the present invention may be varied to make them more or less easy to be removed from the uterus as circumstances may require.

It will be further apparent that because of the presence of the relatively stiff metal portions in the device and the resilience of the rib extension along the margins of its end portion, the device, except when under pressure of muscular tensions, will remain in extended position within the uterus for maximum effectiveness.

It will be still further apparent that numerous variations and modifications may be made in the intrauterine contraceptive devices of the present invention, by anyone skilled in the art, in accordance with the principles of the invention hereinabove set forth, without the exercise of any inventive ingenuity.

What I claim is:

1. An intra-uterine contraceptive device, comprising a body formed of a plurality of substantially straight, stiff elements, including straight end elements each having a free end, and straight intermediate elements between said end elements, said intermediate elements each connected by each of its ends to and end of an adjacent element in extended, divergent relation to said adjacent element by an arcuate, resilient joint to form a continuous structure, said elements normally disposed in extended position relative to one another and compressible towards one another for insertion into a uterus, at least each of said end elements covered by a sheath formed of an inert, resilient pliable material, said sheaths having rib-like extensions projecting beyond the free ends of said end! elements and offset towards and merging with one another to limit expansion of said end of the body upon compression of the other end thereof, said rib like extensions being capable of being flexed to be longitudinally offset relative to the plane defined between said end elements and of being offset toward one another by being pulled outwardly at their point of merger to thereby converge said end elements and facilitate withdrawal of the device from the uterus.

2. The intra-uterine contraceptive deviceof claim 1, wherein a diaphragm of said material extends between said sheaths, said end elements, and said rib-like extensions.

.3. The intra-uterine contraceptive device of claim 2, wherein portions of said rib-like extensions project beyond said end elements and in substantial alinement therewith, and said diaphragm extends between said alined rib-like portions and said offset extensions thereof, whereby a deformable extension is provided on said body adapted to be narrowed and foreshor tened in conformity with the size and shape of a uterus.

4. The intra-uterine contraceptive device of claim 3, wherein said body is formed of metal leaf spring and is of M shape and said free ends of said end elements are in substantial alinement with one another and with the outer end of the joint connecting the adjacent ends of said intermediate elements.

5. The intra-uterine contraceptive device of claim 2, wherein'said offset portions of said rib extensions are substantially alined and merged to form a string-like appendage.

6. The intra-uterine contraceptive device of claim 2, wherein said offset portions are outwardly convergent and merge to form a string-like extension.

7. The intra-uterine contraceptive device of claim 1, wherein said resiliently pliable material comprises a latex.

8. The intra-uterine contraceptive device of claim 1, wherein said body is formed of metal.

9. The intra-uterine contraceptive device of claim 1, wherein said body is formed of leaf spring and is of M shape, and said sheath is formed around all of the elements of said body.

. 10. The intra-uterine contraceptive device of claim 1, wherein said body is formed of spring wire arranged in a flattened spiral, and comprise an even number of elements, alternate of which are disposed in a plane spaced from and parallel to the others, each said sheath enclosing therewithin one of said end elements and the element to which it is connected, said sheath maintaining the end of said end element in proximity to said tensions and said convergent extensions.

13. The intra-uterine contraceptive device of claim 1, wherein a relatively thick layer of soft, readily compressible material, inert to body fluids is secured to portions of said sheath around said end elements on the side edges of said body.

14. The intra-uterine contraceptive device of claim 13, wherein said layer comprises plastic sponge material. 

1. An intra-uterine contraceptive device, comprising a body formed of a plurality of substantially straight, stiff elements, including straight end elements each having a free end, and straight intermediate elements between said end elements, said intermediate elements each connected by each of its ends to and end of an adjacent element in extended, divergent relation to said adjacent element by an arcuate, resilient joint to form a continuous structure, said elements normally disposed in extended position relative to one another and compressible towards one another for insertion into a uterus, at least each of said end elements covered by a sheath formed of an inert, resilient pliable material, said sheaths having rib-like extensions projecting beyond the free ends of said end elements and offset towards and merging with one another to limit expansion of said end of the body upon compression of the other end thereof, said rib like extensions being capable of being flexed to be longitudinally offset relative to the plane defined between said end elements and of being offset toward one another by being pulled outwardly at their point of merger to thereby converge said end elements and facilitate withdrawal of the device from the uterus.
 2. The intra-uterine contraceptive device of claim 1, wherein a diaphragm of said material extends between said sheaths, said end elements, and said rib-like extensions.
 3. The intra-uterine contraceptive device of claim 2, wherein portions of said rib-like extensions project beyond said end elements and in substantial alinement therewith, and said diaphragm extends between said alined rib-like portions And said offset extensions thereof, whereby a deformable extension is provided on said body adapted to be narrowed and foreshortened in conformity with the size and shape of a uterus.
 4. The intra-uterine contraceptive device of claim 3, wherein said body is formed of metal leaf spring and is of M shape and said free ends of said end elements are in substantial alinement with one another and with the outer end of the joint connecting the adjacent ends of said intermediate elements.
 5. The intra-uterine contraceptive device of claim 2, wherein said offset portions of said rib extensions are substantially alined and merged to form a string-like appendage.
 6. The intra-uterine contraceptive device of claim 2, wherein said offset portions are outwardly convergent and merge to form a string-like extension.
 7. The intra-uterine contraceptive device of claim 1, wherein said resiliently pliable material comprises a latex.
 8. The intra-uterine contraceptive device of claim 1, wherein said body is formed of metal.
 9. The intra-uterine contraceptive device of claim 1, wherein said body is formed of leaf spring and is of M shape, and said sheath is formed around all of the elements of said body.
 10. The intra-uterine contraceptive device of claim 1, wherein said body is formed of spring wire arranged in a flattened spiral, and comprise an even number of elements, alternate of which are disposed in a plane spaced from and parallel to the others, each said sheath enclosing therewithin one of said end elements and the element to which it is connected, said sheath maintaining the end of said end element in proximity to said connected element whereby said body is given a tapered shape.
 11. The intra-uterine contraceptive device of claim 10, wherein said offset rib-like extensions encompass transversely the joints connecting said intermediate element at said end of said body.
 12. The intra-uterine contraceptive device of claim 10, wherein said sheaths are each formed with a further rib-like extension outwardly convergent toward one another and merging to form a string-like element and a membrane is connected between its offset rib-like extensions and said convergent extensions.
 13. The intra-uterine contraceptive device of claim 1, wherein a relatively thick layer of soft, readily compressible material, inert to body fluids is secured to portions of said sheath around said end elements on the side edges of said body.
 14. The intra-uterine contraceptive device of claim 13, wherein said layer comprises plastic sponge material. 